DENVER, NC / December 27th, 2018 / CVR Medical Corp. (CVM.V) (TSXV: CVM) (OTCQB: CRRVF) (“CVR Medical”) a Canadian listed and US based healthcare company in the medical device sector announces in follow-up to the previously released press release on December 13th, that its patented Carotid Stenotic Scan (CSS) has passed the IEC 60601-1, General Requirements for Basic Safety and Essential Performance – Electrical Safety testing conducted by TUV Rheinland of North America. This, combined with the previously announced EMC testing, concludes all required medical electrical equipment testing mandated for submission by the US FDA. TUV Rheinland of North America, is one of the leading providers of product safety certifications worldwide, covering an assortment of items such as medical devices, home appliances, audio/video products, medical products, textiles and telecommunication equipment The International Electrotechnical Commission (IEC), based in Geneva, Switzerland, publishes the 60601 series of technical standards that allow medical device developers to demonstrate the safety and essential performance of their medical equipment. Upon completion of EMC testing, TUV North America started IEC 60601-1 safety testing which includes, software and hardware validation , fire and electrical safety and mechanical failure. With the receipt of the EMC and Electrical Safety Reports provided by TUV upon completion of the testing, CVR is now finalizing all documentation for the near immediate FDA submission. As announced, CVR’s previous guidance relating to FDA submission remains unchanged for Q1 2019.
About CVR Medical
CVR Medical Corp. is a healthcare company that operates in the medical device industry focused on the commercialization of its disruptive, proprietary CSS Device. The CSS device is a diagnostic tool that encompasses subsonic, infrasonic, and low frequency sound wave analysis technology. The CSS Device is a patented device designed to detect and measure carotid arterial stenosis. CVR is currently in pivotal clinical trials in preparation for its planned submission to the FDA. CVR is led by an experienced and proven team of professionals with extensive healthcare, medical device, international expansion, regulatory and sales experience. CVR Medical trades on the TSX Venture Exchange under the symbol CVM.
Additional information regarding the Company can be found in our recent filings with the SEDAR as well as the information maintained on our website at www.cvrmed.com
ON BEHALF OF THE BOARD: (signed) “Peter Bakema” CEO, President & Director